NCT00253058

Brief Summary

To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P50-P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
Last Updated

May 6, 2013

Status Verified

May 1, 2013

First QC Date

November 11, 2005

Last Update Submit

May 3, 2013

Conditions

Rhinitis, Allergic, Perennial

Keywords

AllergicpediatricRhinitisPerennial

Outcome Measures

Primary Outcomes (1)

  • change in the total nasal symptom score (TNSS)

Secondary Outcomes (1)

  • - Individual daily nasal symptom score - Investigator global improvement/patient global improvement - Nasal findings - Cetirizine serum concentrations - Adverse events

Interventions

Cetirizine Dry SyrupDRUG

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with perennial allergic rhinitis.
  • Giving informed consent.
  • Children with a positive response to specific IgE antibody test.
  • Children assessed as positive in the nasal eosinophil count.
  • Children whose severity score of nasal symptom is 4 or higher.

You may not qualify if:

  • have spastic disease such as epilepsy
  • have a history of drug hypersensitivity
  • are pregnant, lactating or possibly pregnant female Children
  • are sensitive to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods
  • have vasomotor rhinitis and eosinophilic rhinitis
  • have asthma that requires the treatment with corticosteroid
  • have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs
  • have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation
  • have started specific desensitization treatment or nonspecific modulation treatment but who have not reached the maintenance level of treatment
  • have received surgical treatment for reduction and modulation of nasal mucosa
  • redintegration therapy of nasal cavity to improve the degree of nasal airway
  • surgical operation to improve rhinorrhea.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Location

MeSH Terms

Conditions

Rhinitis, Allergic, PerennialRhinitis

Condition Hierarchy (Ancestors)

Rhinitis, AllergicNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfections

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

July 1, 2005

Last Updated

May 6, 2013

Record last verified: 2013-05